Biofire Diagnostics, LLC

Biofire Diagnostics, LLC — FDA 510(k) Submissions

Biofire Diagnostics, LLC has submitted 28 FDA 510(k) premarket notifications since 2015, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents, Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System, Gram-negative Bacteria And Associated Resistance Markers, Respiratory Virus Panel Nucleic Acid Assay System, Respiratory Panel . Use the specialty filter in the sidebar to narrow results.